Very-low-birth weight (VLBW) infants with a birth weight less than 1500 grams are a significant public health concern, comprising 57,000 deliveries per year at a cost of over 4 billion dollars for medical care. Regionalization policies have been developed to optimize the care of these high-risk newborns, centralizing the care of VLBW infants at a few specialized hospitals within a defined geographic region. However, these policies have recently weakened in many areas of the US. How these shifts in policy have affected the quality of neonatal care and patient safety is unknown, since prior work has been limited by (1) selection bias; (2) poor control of casemix severity; and (3) the lack of a uniform measure of the degree of regionalization in the areas of interest. To address these methodological issues, this proposal will use an instrumental variables approach to answer the following specific aims: (1) to quantify the difference in the quality of neonatal care between hospitals; (2) to determine the effect of perinatal de-regionalization on the rates of mortality, failure-to-rescue, complication, and 21-day readmission in VLBW infants; and (3) to develop a predictive model that explains neonatal outcomes as a function of the quality of neonatal care and regionalization policy in a given geographical area. This project will use population data from the years 1992 to 2002 in three states that have an estimated 12,800 VLBW births per year. Two-stage regression techniques will be used to control for measured confounders, while various instruments including the differential travel time from the residential zip code to regional center and to the nearest delivery hospital will be used to control for unmeasured bias. The study will be powered to find small differences in neonatal outcomes and determine the effect of regionalization policies on neonatal quality of care with less bias than previous work. Results from this study will allow policy makers to develop perinatal regionalization policies for individual areas after accounting for geographic differences in hospital quality and population, improving the quality and safety of care for VLBW infants. This improvement in the quality of neonatal care delivered to this high-risk population of infants should result in short and long-term improvements in the public health, outcome, and medical-related costs of caring for VLBW infants. [unreadable] [unreadable] [unreadable] [unreadable]